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In sub-Saharan Africa, engaging men in HIV prevention, care, and treatment has proven challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking behaviors than women. They are less likely to be tested for HIV, initiate combination antiretroviral therapy (cART), and be retained in cART care. Additionally, men rarely engage in the care of their female sex partners, even though couple care-seeking is associated with marked improvements in condom use within HIV-discordant couples. Option B+, Malawi's program for providing immediate, lifelong combination antiretroviral therapy (cART) to all HIV-infected pregnant women at the time of diagnosis, is an important entry-point for involving male partners in care.
This is a pilot randomized controlled trial (N=200 women) comparing two strategies of male partner involvement within the Option B+ program. In both arms (patient referral and contract referral) women will be encouraged to invite their male partners to accompany them to the clinic for couple HIV counseling and testing. In the contract referral arm, if the couple does not present within one week, the male partner will receive a home visit encouraging them to present to the clinic. We will compare the two arms for 1) uptake of couple HIV counseling and testing (cHCT), 2) uptake of cART for women, and 3) linkage to care for HIV-infected men. Results are expected to inform a larger trial and ultimately improve care-seeking in Malawi's HIV program.
Objective 1: Determine acceptability of male partner recruitment for cHTC within an Option B+ context. We will assess acceptability of eligible females to participate in this pilot RCT and reasons for non-participation.
Objective 2: Assess whether study arm (patient referral versus contract referral) is associated with cHTC uptake. We will conduct a pilot randomized controlled trial (RCT) of male partner recruitment. This study will contain two arms: patient referral and contract referral for uptake of cHTC (primary outcome).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient referral | Active Comparator | Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information |
|
| contract referral | Experimental | Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| contract referral | Behavioral | A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Women Who Came With Their Partners and Received Couple Counseling and Testing | Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake. We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test. | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Female First Option B+ Follow-up Visit | It will be assessed whether the female participants return for their first Option B+ visit (using the clinic's routine Option B+ records). The number retained will be compared. | three months |
| Male Linkage to Care |
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Inclusion Criteria:
18 years old or 16-17 years old and married
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nora E Rosenberg, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Mina Hosseinipour, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bwaila District Hospital Antenatal Unit | Lilongwe | Central District | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26520928 | Derived | Rosenberg NE, Mtande TK, Saidi F, Stanley C, Jere E, Paile L, Kumwenda K, Mofolo I, Ng'ambi W, Miller WC, Hoffman I, Hosseinipour M. Recruiting male partners for couple HIV testing and counselling in Malawi's option B+ programme: an unblinded randomised controlled trial. Lancet HIV. 2015 Nov;2(11):e483-91. doi: 10.1016/S2352-3018(15)00182-4. Epub 2015 Oct 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Referral | Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation. |
| FG001 | Contract Referral | Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community. patient referral: A patient agrees to recruit their partner using the invitation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
HIV-infected women eligible for Option B+
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Referral | Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation. |
| BG001 | Contract Referral |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Women Who Came With Their Partners and Received Couple Counseling and Testing | Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake. We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test. | Posted | Number | Female participants receiving CHTC | three months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Referral | Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| social disruptions reported by women | Social circumstances | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nora Rosenberg, PhD | UNC Chapel Hill/UNC Project Lilongwe | +265 (0)99 109 0676 | Nora_Rosenberg@unc.edu |
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| ID | Term |
|---|---|
| D016358 | Contact Tracing |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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|
| patient referral | Behavioral | A patient agrees to recruit their partner using the invitation. |
|
|
It will be assessed whether newly diagnosed HIV-infected male partners are linked to care within one month of learning their HIV positive result with their partner. This will be assessed from abstraction of routine clinic records at Martin Preuss Center. |
| one month from male presentation to the clinic |
Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community. patient referral: A patient agrees to recruit their partner using the invitation. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.
contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
|
|
| Secondary | Female First Option B+ Follow-up Visit | It will be assessed whether the female participants return for their first Option B+ visit (using the clinic's routine Option B+ records). The number retained will be compared. | Posted | Number | participants | three months |
|
|
|
| Secondary | Male Linkage to Care | It will be assessed whether newly diagnosed HIV-infected male partners are linked to care within one month of learning their HIV positive result with their partner. This will be assessed from abstraction of routine clinic records at Martin Preuss Center. | These are only the HIV-infected men who participated in the study who were HIV-infected and not already engaged in care. That is why it is only a subset of the larger population. | Posted | Number | partners linked to care | one month from male presentation to the clinic |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Contract Referral | Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community. | 0 | 100 | 3 | 100 |
|
| social disruption reported by men | Social circumstances | Non-systematic Assessment | Men who reported disruptions related to tracing or study participation. |
|
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| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |